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CTRI Number  CTRI/2023/09/057270 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 04/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the effect of intravenous clonidine versus dexmedetomidine on blood pressure and heart rate during laparoscopic cholecystectomy  
Scientific Title of Study   A randomised controlled trial to compare the effect of intravenous clonidine versus dexmedetomidine on hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chiteshwar walia 
Designation  Associate Professor 
Affiliation  Sr Guru Ram Das Institute of Medical sciences and Research 
Address  Department of anaesthesia,

Amritsar
PUNJAB
143001
India 
Phone  9878339933  
Fax    
Email  chiteshwarwalia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gurleen Kaur 
Designation  Junior Resident 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia

Amritsar
PUNJAB
143001
India 
Phone  9780417889  
Fax    
Email  drgurleendhaul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harpreet Babrah 
Designation  Assistant Professor 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research 
Address  Department of Anaesthesia

Amritsar
PUNJAB
143001
India 
Phone  9023448624  
Fax    
Email  docharpreet21@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research 
 
Primary Sponsor  
Name  Sri Guru Ram Das Institute of Medical sciences and Research 
Address  Main Operation Theatre, Department of anaesthesia 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Gupta  Sri Guru Ram Das Institute of Medical Sciences and Research  OT no 2 and 4, Main Operation Theatre,Department of anaesthesia,
Amritsar
PUNJAB 
9814020805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  General anaesthesia  premedication of receiving clonidine 0.75 μg/ kg in normal saline or dexmedetomidine 0.75 μg/ kg in normal saline(15 min) 
Comparator Agent  Normal saline  receiving 50 ml of normal saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA grades I and II
 
 
ExclusionCriteria 
Details  1. Patients not giving consent
2. Any heart block, preexisting hypertension, cardiovascular disease
3. Hepatic and renal disease
4. Allergies to the drugs used
5. Acute cholecystitis
6. Pregnant ladies and lactating mothers
7. Patients taking clonidine, methyl-dopa, beta-blocking drugs, benzodiazepines, MAO inhibitors
8. Morbidly obese
9. Open cholecystectomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy  from the giving of study drug till the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
1) Effect of intravenous clonidine on hemodynamic response during laparoscopic cholecystectomy
2) Effect of intravenous dexmedetomidine on hemodynamic response during laparoscopic cholecystectomy
3) Effect of intravenous normal saline on hemodynamic response during laparoscopic cholecystectomy
4) To compare the effect of all three 
before induction to 5 min after extubation 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Background: Laparoscopic cholecystectomy is the treatment of choice for symptomatic benign gall bladder diseases and has essentially replaced the open technique because of its better postoperative recovery profile. But it is also associated with significant cardiopulmonary changes due to the pressure effect of pneumoperitoneum and the release of catecholamine. Various drugs have been used to prevent these responses like magnesium sulfate, nitroglycerine, clonidine, and dexmedetomidine. Clonidine, a selective alpha-2 adrenergic agonist, and dexmedetomidine, a new generation highly selective alpha-2 adrenoreceptor agonist, inhibit catecholamine release effectively and will be used in this study for achieving haemodynamic stability.
Objectives: To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy.
Material And Methods: in three groups of 30 each randomly selected patients, one group will receive 50 ml of normal saline, the second group will receive 0.75μg/kg clonidine in normal saline, the third group will receive 0.75μg/kg dexmedetomidine in normal saline and total volume of study drug will be adjusted to 50 ml each administrated for 15 minutes before induction of GA.
Expected Benefits: in terms of stable hemodynamics, reduction in induction dose of propofol, decreased post-operative pain, and decreased side effects.
 
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